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Completed

NCT Number: NCT03860675

Assessment of Walking-related Fatigability in Patients With Multiple Sclerosis.

The primary goal of this interventional study is to objectively examine the prevalence of walking-related performance fatigability, together with the psychometric properties of its measuring parameters. The secondary aim is to investigate the relation of other clinical symptoms to walking-related performance fatigability.

The following three research questions will be addressed:

1. How prevalent is walking-related performance fatigability and what are the psychometric properties of fatigability formulas in preparation of use as experimental outcome measure? 2. What are associated symptoms of walking-related motor fatigability and how long does this manifest? 3. What is the relationship between cognitive fatigability and walking-related performance fatigability?

participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University, Diepenbeek, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 - 70 years
  • Confirmed diagnosis according to the McDonald criteria
  • Performed a 6MWT before, to ensure familiarization
  • Able to walk independently or with unilateral support for 6 minutes without rest
  • Signed the informed consent

Exclusion criteria

  • Exacerbation or relapse within last 3 months before study
  • Other neurological diagnosis, such as stroke and Parkinson
  • MS-like syndromes, such as neuromyelitis optica
  • Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia)

Treatment and study plan

Assessment of walking-related fatigability

Diagnostic Test

participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.

Primary outcomes

  1. Deceleration index

    Time frame: day 1

    Formula for walking-related performance fatigability: (distance min6 - distance min1)/(distance min1) x100 Cut-off value: -15%

Secondary outcomes

  1. Symptom Inventory Questionnaire

    Time frame: day 1

    Visual analog scale for the 11 symptoms of the SI: General fatigue, motor fatigability, attention problems, spasticity, sensitivity, visual disturbance, balance disturbance, gait pattern impairments, pain, dizziness, muscle weakness (pre/post/10'post/20'post/30'post 6MWT)

  2. Symptom Inventory Questionnaire

    Time frame: day 4

    Visual analog scale for the 11 symptoms of the SI: General fatigue, motor fatigability, attention problems, spasticity, sensitivity, visual disturbance, balance disturbance, gait pattern impairments, pain, dizziness, muscle weakness (pre/post/10'post/20'post/30'post 6MWT)

  3. spasticity

    Time frame: day 1

    Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)

  4. spasticity

    Time frame: day 4

    Modified Ashworth Scale for spasticity (0 - 1 - 1+ - 2 - 3 - 4) (pre/post/10'post/20'post/30'post 6MWT)

  5. Strength

    Time frame: day 1

    Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)

  6. Strength

    Time frame: day 4

    Motricity Index for muscle strength (0 - 9 - 14 - 19 - 25 - 33) (pre/post/10'post/20'post/30'post 6MWT)

  7. Balance

    Time frame: day 1

    Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)

  8. Balance

    Time frame: day 4

    Romberg test for balance (pre/post/10'post/20'post/30'post 6MWT)

  9. VAS fatigue

    Time frame: day 1

    Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)

  10. VAS fatigue

    Time frame: day 4

    Visual analog scale for fatigue pre 6MWT and after each minute of 6MWT (0 - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10)

  11. heart rate

    Time frame: day 1

    Heart rate pre 6MWT and after each minute of 6MWT

  12. heart rate

    Time frame: day 4

    Heart rate pre 6MWT and after each minute of 6MWT

  13. gait parameter

    Time frame: day 1

    APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.

  14. gait parameter

    Time frame: day 4

    APDM opal sensors: sensors to analyze the spatiotemporal parameters of gait while walking for 6minutes.

  15. Cognitive fatigability

    Time frame: between week 1 and week 2 (no specific day: at the day the patients request)

    deceleration of reaction time of answers of the Alphabeth vigilance test six minutes while walking and the Alphabeth vigilance test six minutes in rest.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt

Registry information

Official study title

Clinical Profiling, Manifestation and Assessment of Walking-related Performance Fatigability in Patients With Multiple Sclerosis: a Cross Sectional Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2019
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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